Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012621958228 Date of Approval: 17/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preemptive analgesic efficacy of bilateral retrolaminar block in pediatric cardiac surgery
Official scientific title Preemptive analgesic efficacy of bilateral retrolaminar block in pediatric cardiac surgery
Brief summary describing the background and objectives of the trial Single shot regional anesthetic techniques can reduce the intensity of postoperative pain for up to 24 h after pediatric open-heart surgery. Neuraxial regional anesthesia including caudal, epidural, paravertebral and spinal blockade have been studied, but their use is limited and not gained any popularity, because of the potential risk of epidural hematoma in the fully heparinized patients. Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional paravertebral block. We hypothesized that; bilateral thoracic retrolaminar block would reduce perioperative opioids requirements in such patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/12/2020
Actual trial start date 15/12/2020
Anticipated date of last follow up 15/12/2021
Actual Last follow-up date 15/12/2021
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Retrolaminar group 0.2–0.4 mL/kg, 0.25% bupivacaine After induction of anesthesia To perform the block the patient is put on the prone position, then the suggested ultrasound transducer orientation is sagittal paramedian (cephalacaudad direction). We begin our ultrasound scanning in a paramedian sagittal plane by finding desired level (T4-T5).The transverse process view, the costotransverse ligament can be visualized above the paravertebral space. Continuing to scan from lateral to medial, the vertebral laminae come into view. The dose of local anesthetic (bupivacaine 0.25%) for retrolaminar block in pediatric was not described in any previous literature. This block requires the injection of large volumes of local anesthetic (0.2–0.4 mL/kg, 0.25% bupivacaine), where it can spread to the paravertebral space, accordingly, we used 0.4 mL/kg of 0.25% bupivacaine on each side. 32
Control Group Placebo group 0.4 ml/kg normal saline After induction of anesthesia To perform the block the patient is put on the right side, then the suggested ultrasound transducer orientation is sagittal paramedian (cephalacaudad direction). We begin our ultrasound scanning in a paramedian sagittal plane by finding desired level (T4-T5).The transverse process view, the costotransverse ligament can be visualized above the paravertebral space. Continuing to scan from lateral to medial, the vertebral laminae come into view. 0.4 ml/kg normal saline will be injected, where it can spread to the paravertebral space, accordingly, we used 0.4 mL/kg of 0.25% bupivacaine on each side. 32 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will be conducted on patients of either sex with the following inclusion criteria 1. Age 2-8 years. 2. Elective corrective open heart surgery using cardiopulmonary bypass (CPB). 1. Patients with previous open heart surgery. 2. Neurological, renal or hepatic disease. 3. Decompensated heart failure. 4. Eisenmenger syndrome or right to left shunts. 5. Presence of preoperative coagulation disorders. 6. Contraindication to use TEE. 7. Hypersensitivity of any of the studied drugs. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 8 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/12/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 elgomhouria st el mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The total dose of fentanyl consumption in the first postoperative 24h after extubation 24 hours postoperative after extubation
Secondary Outcome • Postoperative pain score, • Heart rate (HR) • Mean arterial pressure (MAP) • Total intraoperative fentanyl requirements, • Aortic cross clamping time, • CPB time, • Duration of surgery, • Time to first rescue analgesia, • Time to extubation, • Intensive care unit (ICU) length of stay • The incidence of postoperative complications (pruritus, vomiting, pneumothorax, hematoma or local anesthetic toxicity). • Time to extubation which is defined as the time from ICU arrival till endotracheal extubation. 1, 2, 6, 12, 18 and 24 h after extubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital MUCH 2 el gomhuria st Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university 2 elgomhouria st elmansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university 2 elgomhouria st elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 elgomhouria st. elmansoura 35516 Egypt
Nabil Abd Elraouf Abd Elmageed 2 elgomhouria st. elmansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed Ahmed Maher Ibrahim Elmorsy m.am.elmorsy@gmail.com +201112582480 2 elgomhouria st
City Postal code Country Position/Affiliation
elmansoura 35516 Egypt lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Ibrahim Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com 01004976825 2 elgomhouria st.
City Postal code Country Position/Affiliation
elmansoura 35516 Egypt assistant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Nabil Nabil Abd Elraouf Abd Elmageed Nabil_abdelraouf@yahoo.com +201001538648 2 elgomhouia st.
City Postal code Country Position/Affiliation
elmansoura 35516 Egypt professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper Informed Consent Form,Statistical Analysis Plan,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request m.am.elmorsy@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information